ONDINE BIOMEDICAL
INC.
("Ondine
Biomedical", "Ondine", or the "Company")
Ondine commencing US Phase 3
clinical trial
Ondine Biomedical Inc. (LON: OBI), a
Canadian life sciences company pioneering light-activated
antimicrobial treatments, announces the imminent start of the
LANTERN Phase 3 clinical trial of its novel nasal photodisinfection
technology, branded as Steriwave® outside the US. The
U.S. Food and Drug Administration (FDA) has raised no objections to
starting the study during its statutory 30-day review period of the
Company's Investigational New Drug (IND) amendment, thereby
allowing the trial to begin.
Preparations for this pivotal trial
are nearly complete, with all 14 hospital sites selected and two
additional back-up sites identified. Ondine has already initiated
four sites and has been conducting staff training to ensure
readiness for patient enrolment. Patient recruitment activities are
beginning and will continue through early 2025, with the final
patient expected to enrol in mid-2025. Early trial results are
projected for release in Autumn 2025.
The Phase 3 trial is being conducted
in collaboration with HCA Healthcare, a leading healthcare provider
in the United States. This group-randomized crossover study
will enroll approximately 5,000 surgical patients undergoing
cardiac, orthopedic, vascular, neuro or radical mastectomy
surgeries. The study will compare standard infection prevention
practices with and without Ondine's nasal photodisinfection
technology.
CEO Carolyn Cross stated:
"The significant recent funding has
been pivotal in enabling us to move forward with the launch of our
US Phase 3 trial before the end of the year. This critical study
marks a key milestone in our pursuit of FDA approval for our nasal
photodisinfection technology. We're thrilled by the strong
engagement from our clinical trial investigators and hospital
research teams and are excited to commence the trial with the
support of our clinical trial partner, HCA Healthcare."
Ondine's nasal photodisinfection is
a 5-minute, non-invasive procedure that rapidly decolonizes the nose of infection-causing pathogens
without the use of antibiotics. This innovative approach avoids
contributing to antimicrobial resistance (AMR). The process involves applying a proprietary photosensitive
agent to each nostril with a nasal swab, followed by illumination
with a specific wavelength of red light. The light activates the
agent, producing an oxidative burst that destroys bacteria, viruses
and fungi in a single treatment.
Nasal decolonization is recommended
in the 2016 WHO Global guidelines for the prevention of surgical
site infections,[1] and the Society for
Healthcare Epidemiology of America (SHEA) guidelines, published in
May 2023, recommend nasal decolonization for major surgical
procedures.[2]
Enquiries:
Ondine Biomedical
Inc.
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|
Carolyn Cross, CEO
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+001 (604) 665 0555
|
Singer Capital Markets (Nominated Adviser and Joint
Broker)
|
|
Phil Davies, Sam Butcher
|
+44 (0)20 7496 3000
|
|
|
RBC
Capital Markets (Joint Broker)
|
|
Rupert Walford, Kathryn
Deegan
|
+44 (0)20 7653 4000
|
|
|
Vane Percy & Roberts (Media Contact)
|
|
Simon Vane Percy, Amanda
Bernard
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+44 (0)77 1000 5910
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About Ondine Biomedical Inc.
Ondine Biomedical Inc. is a Canadian
life sciences company and leader in light-activated antimicrobial
therapies (also known as 'photodisinfection'). Ondine has a
pipeline of investigational products, based on its proprietary
photodisinfection technology, in various stages of
development.
Ondine's nasal photodisinfection
system has a CE mark in Europe and is approved in Canada and
several other countries under the name Steriwave®. In
the US, it has been granted Qualified Infectious Disease Product
designation and Fast Track status by the FDA and is currently
undergoing clinical trials for regulatory approval. Products beyond
nasal photodisinfection include therapies for a variety of medical
indications such as chronic sinusitis, ventilator-associated
pneumonia, burns and other indications.